A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Aldesleukin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000849

ACTG 299

11275 (Registry Identifier)

PACTG 299

Details and patient eligibility

About

The purpose of this study is to determine the safety and maximum tolerated dose (the highest dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children. This study also evaluates the effect of rIL-2 on the immune system of these patients.

IL-2 is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. HIV-infected patients do not produce enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in these patients. First, it is necessary to determine the safety and effectiveness of this drug in HIV-infected children.

Full description

According to study records, IL-2 has not been tested in HIV-infected children. Experience with IL-2 in pediatric populations is extremely limited. Pahwa et al. gave 30,000 units/kg daily IV to a child with severe combined immunodeficiency. This dose was well tolerated and the patient improved clinically as well as immunologically. Part A is necessary to determine the maximum tolerated dose of IL-2 in infected children. Part B will determine the efficacy of the maximum tolerated dose in infected children.

Part A: Children will receive rIL-2 intravenously for 5 days every 8 weeks for 3 cycles. The study will enroll 4 patients in each of 3 dose levels. Dose escalation may occur if all 4 patients in a dose level tolerate therapy without evidence of Grade 3 (or higher) toxicity. If 1 of 4 subjects in any dose level experiences at least Grade 3 toxicity, 2 additional patients will be enrolled in that dose level. If 1 of these 2 additional patients experiences at least Grade 3 toxicity, dose escalation will not proceed. NOTE: Once Part A is completed and the maximum tolerated dose is established, children who participated in Part A and received less than the maximum tolerated dose will be offered additional therapy consisting of 3 cycles of rIL-2 at the maximum tolerated dose.

Part B: Children will receive rIL-2 intravenously at the maximum tolerated dose established in part A. Treatment will be given for 5 days every 8 weeks for 3 cycles. [AS PER AMENDMENT 6/4/98: Children will receive rIL-2 intravenously at the lowest dose for 5 days every 8 weeks for 6 cycles. Patients who received this dose in part A will also be offered this regimen.]

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Children may be eligible for this study if they:

• Are HIV-positive.
• Have decreased immune system functioning (CD4 count 500-1000 for 3- to 5-year-olds or CD4 count 200-500 for 6- to 12-year-olds).
• Have symptomatic HIV infection.
• Have a viral level less than 400 copies/ml.
• Are between the ages of 3 and 12 (consent of parent or guardian required).

Exclusion Criteria

Children will not be eligible for this study if they:

• Have an active opportunistic infection.
• Are pregnant.